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Post by Dimitri Stamatiadis on Apr 2, 2016 12:33:54 GMT
Dear all,
Here is another discussion topic on which we have exchanged interesting views with members of our group: Should workflows be controlled by the system or can they be managed by procedures. Here is an example of the second option: An author creates a document, optionally invites co-authors to contribute. When the document is near finished, the author invites other people (as stated in the SOPs) to review the draft by viewing it in the system and provide him/her with their comments either orally during a meeting or in writing (e.g. in an email). The author then incorporates any comments and promotes the document to "Approved" with no further processing. The audit trail records who initiated the document and who approved it. If no e-signature is needed, this scenario can work for many documents and does not require the system to lock down the document in the different intermediate states (for review, reviewed, for approval etc). In small organisations where communication is easy, such a process can work well because there is little risk that the document is changed during review or that the appropriate people do not review it.
Any thought or strong opinions?
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Post by Steve Scribner on Apr 4, 2016 14:32:20 GMT
Flexibility.
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Post by Sophie Durand on Apr 6, 2016 9:21:04 GMT
Give the option to users as they may prefer the simple procedural control for several types of documents but may want to use controlled workflows for some key documents.
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Adair Turner
New Member
Director of Regulatory and Clinical Operations at arivis
Posts: 2
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Post by Adair Turner on May 17, 2016 23:04:35 GMT
I agree that it needs to be flexible and configurable. I work with quite a few start-up companies and they want to author, review, and approve documents outside of the system and import the document when final or close to final. Also keep in mind that they are usually working with outside vendors and consultants and maintain a skeleton internal staff. In my experience, they also don't use statuses except draft and final.
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Nikolaj
New Member
Director of Document and Quality Systems at Epista Life Science
Posts: 3
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Post by Nikolaj on Jul 20, 2016 5:37:19 GMT
The systems should definitely have an option to force the use of workflows. If desired, this can be set up so it is optional for the users. However, I think the best way to achieve this is to have some kind of power-promotion as suggested. In addition, I believe that it needs to be configurable on a per document type level. You might have some very controlled documents which you want to ensure always follows the right path. Other documents you can be more loose about. In particular I am thinking of documents which needs to be approved by QA. It should be possible to “hard-code” this into the workflow and have the system ensure that only people from QA can be selected for this step in the workflow. One of the whole ideas of getting an EDMS is to obtain more control.
Nikolaj
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Post by Dimitri Stamatiadis on Sept 12, 2016 19:43:18 GMT
Not necessarily. SOPs are there for that. Too much structure makes a system "hated" by users. Especially in small companies where 1) communication is easy and 2) there is no culture of the automation.
My two cent but this is a forum and all opinions are respected.
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